midterm Flashcards
3 guiding principles of belmont report
- Respect for persons - informed consent and protection of vulnerable populations
- beneficence - do not harm. maximize benefits and minimize risk
- Justice - fair and equal treatment in bearing burdens and receiving benefits of research. Include diverse populations
persons with diminished autonomy entitled to protection
children
mentally disabled
prisoners
informed consent process (respect for persons)
gives enough info to decide wether or not to participate
gives comprehension through understandable language and answering question
voluntariness free of coercion or influence
IRB must consider
risk to subjects
benefits to subjects
importance of knowledge to be gained
informed consent process
IRB must report to federal agencies what?
- Injuries to human subjects or unanticipated problems
* Serious or continuing noncompliance with regulations or IRB requirements
what is consent?
consent must be informed, understood, and voluntary
Office for Human Research Protection (OHRP)
oversees Assurances –US institutions as well as international institutions receiving DHHS funds for research
federally funded research cannot be conducted until assurance is re-instated
has authority to terminate or suspend institution’s research
Federal-Wide Assurance (FWA) aka assurance of compliance is needed before?
a federal grant or contract is awarded to institutions
FWA makes institution agree to federal regulations
Federal-Wide Assurance (FWA) aka assurance of compliance is needed before?
a federal grant or contract is awarded to institutions
FWA makes institutions agree to apply federal regulations
IRB acts as?
federal government in conducting duty of supervising research
IRB acts as?
federal government in conducting duty of supervising research
research study with prisoners must be?
applicable to health concerns in prison setting like
hepatitis
good clinical practice
protect participants
good clinical practice branches?
FDA 21 CFR
OHRP (DHHS) 45 CFR 46
International council for harmonisation (ICH)
state and local regulations general rule
federal laws must be followed if stricter than state regulations
whichever is stricter must be followed
21 CFR FDA regulated research
regulates:
financial disclosure for drug development
IRB
how long are study records maintained?
minimum of 2 years after FDA approval or discontinuation
3 yrs after completion of study for DHHS
ICH
international board that sets standards for the pharmaceutical industry
confidentiality certificate
protects information about subjects against a legal order to discover data
given by NIH and IRB tells you to get it
levels of IRB protocol review
exempt - review protocols that are minimal risk. usually retrospective. IRB not required if subject cannot be identified. ONLY IRB decides if exemption applies or not
expedited - reviews protocols that are minimal risk and can be retrospective or prospective. having 3 members of IRB can give you permission instead of the full board. may not be allowed if subject ID poses risk of privacy protection. consent can be waived
full board - for research with greater than minimal risk
levels of IRB review
exempt - reviews protocol that are minimal risk. usually retrospective. IRB not required if subject cannot be identified. ONLY IRB decides if exemption applies or not
expedited - review protocol that are minimal risk and can be retrospective or prospective. having 3 members of IRB can give you permission instead of the full board. may not be allowed if subject ID poses risk of privacy protection. consent can be waived
full board - for research with greater than minimal risk
informed consent review lets subjects know about?
risks purpose benefits disclosure confidentiality compensation answers to questions voluntariness
protocol deviations
decrease credibility of data and affect licensing of drug
adverse event
any deterioration in health status wether or not associated with drug must be reported
like hospitalization, a finding in PE, symptom,
adverse drug rxn
due to a drug must also be reported
unexpected adverse event
new event not listed on risk information in protocol or investigator brochure.
serious adverse events must be reported to IRB within?
24 hours
final rule
no research misconduct by fabrication, falsification or other practices that deviate from scientific community
intentional flaw
what are the simple concepts that drive decision making when implementing clinical trials?
subject welfare
data validity
control of investigational product
Good Clinical Practice in US
FDA 21 CFR
Electronic documents informed consent
Financial disclosure
IRBs
IND (investigational new drug) and NDA (new drug application)
Biologics
devices
Good Clinical Practice in US
OHRP (DHHS) 45 CFR 46
IRBs and informed consent
Protection of pregnant women, fetuses, neonates, prisoners, children
Registration of IRB
Good Clinical Practice in US
ICH
International board that sets standards for pharmaceutical industry
Expected adverse event vs unexpected adverse event
expected adverse event - adverse experience/ risk information in sponsor protocol or investigator brochure
unexpected adverse event - any adverse experience not constistent with risk info described in sponsor protocol or investigator brochure
